Clinical Trials in Europe: 10 Essential Tips for US Sponsors
In this expert guide, Chris Moore, Senior Clinical Project Manager at Boyds, shares 10 essential considerations for U.S. biotechs looking to set up successful clinical trials in Europe under the new Clinical Trials Regulation (CTR) and CTIS system.
Understanding the aims of the EU COMBINE project
The European Union (EU) has one of the most advanced regulatory frameworks for healthcare innovation in the world. However, this complexity can pose significant challenges, particularly when clinical studies involve more than one category of health technology.
Five top tips for securing marketing authorization in Europe
In this blog, Dr Katherine Bowen, Chief Regulatory Affairs Officer at Boyds, provides her top tips for obtaining EU marketing authorization through the centralised procedure.
Exploring the FDA’s draft guidance on AI in regulatory decision-making
In January 2025, the Food and Drug Administration (FDA) issued long-awaited draft guidance on the use of artificial intelligence (AI) in regulatory decision-making for drugs and biological products. In this blog, the Boyds Regulatory Affairs team outlines the new guidance and its aims.
Navigating the Regulatory Landscape of Rare Disease Drug Development
Recognizing Rare Disease Day and Its Impact. February 28, 2025, marks Rare Disease Day – a global initiative dedicated to raising awareness and driving change for the 300 million people worldwide living with a rare disease, along with their families and carers.
US growth journey: boosting the Boyds brand stateside
To meet growing demand for our expertise and services in the US, Boyds established a physical presence stateside in 2021, recruiting US regulatory and program management professionals to our team. As we head into 2025, we take a look back at Boyds’ US growth journey to date.
Navigating the complex regulatory landscape of medical devices in the EU
In this blog, Eamonn McGowran, Associate Director of Regulatory Affairs at Boyds, discusses the changes and key considerations for developers navigating the regulations, especially when managing combination products that integrate both devices and medicinal products.
EU AI Act: considerations for medical device developers
In this blog, Eamonn McGowran, Associate Director of Regulatory Affairs at Boyds explains the scope of the Act and key considerations for medical device developers.
Why work with an Interim Chief Medical Officer?
In this article, Dr Karen Mullen, Chief Medical Officer at Boyds, explores the benefits and value of hiring an interim Chief Medical Officer.
Patient advocacy: the critical role of patient engagement in clinical trials
In this blog, Chris Moore, Senior Clinical Project Manager at Boyds, explores the role of patient and public advocacy and engagement in the clinical trial planning process.
